Spain, a pioneer country against counterfeiting drugs

June 8, the World Day against Counterfeiting and Piracy is celebrated
Our country was one of the first and with the highest volume of activity to connect with the European hub for the verification of medicines, in application of the directive of the European Union

More than 1,450 million drug presentations already have a unique identifier that prevents counterfeit drugs from entering the official supply chain

Source: www.farmaindustria.es

Like every June 8, today is the World Day against Counterfeiting and Piracy, an aspect in which Spain is at the forefront of Europe in the field of medicines. The Spanish Drug Verification System (SEVeM) was one of the national entities that, with the greatest speed and volume of activity, connected, in February 2019, to the European hub against counterfeiting, which made our country one of the first in adopting the new European directive. Since then, thanks to this collaborative project of the entire pharmaceutical sector – manufacturing laboratories, distributors and pharmacies – in Spain, it is possible to differentiate one medicine container from another by means of a unique identifier, making it virtually impossible for counterfeit drugs to enter the chain. legal supply.

Thanks to the platform, launched by Farmaindustria, the Spanish Association of Generic Medicines (Aeseg), the Federation of Pharmaceutical Distributors (Fedifar) and the General Council of Pharmaceutical Colleges, currently more than 1,450 million drug presentations already have a unique identifier, which has allowed more than 285 million containers to be verified by this system at this time (with an average activity of 2 million verified containers per day). 465 drug marketing authorization holders (TACs), 302 distribution warehouses, almost all pharmacies (22,100) and 178 hospitals have already connected to the Spanish platform.

A two-device system

The anti-counterfeiting drug system affects prescription drugs that have to be provided with two security devices since then. The pharmaceutical manufacturing companies in Spain had to adapt all their production lines to be able to include these devices in all drug boxes, which represented an investment of approximately 200 million euros.

The first device is a unique identifier (in the form of a datamatrix code) that contains the product code, a 20-character serial number generated by a scrambling algorithm, the batch number, and the expiration date. In this way, the authenticity is verified and each medication container is individually identified through a telematic connection between the pharmacy and the repository of authentic codes at the time of dispensing. Additionally, in the case of Spain, and at the request of the national authorities, the datamatrix code also contains the national refund number, either within the product code itself or in another field.

The second security device is an anti-tamper system to guarantee that the container has not been opened from its exit from the production chain until its dispensation in the pharmacy office.

In the first year of SEVeM’s operation – which took place on February 9 – more than 770 million operations had been carried out in Spain, with a success rate of 98%. Due to the size of the project, there is a period of stabilization of the system until it reaches 100% operation. In addition, it must be borne in mind that the maximum expiration date of the medicines is established in five years, for which reason all the products put on the market before February 9 of last year have not yet been released and do not have the safety devices of the new procedure.

Last week was the World Day Against Counterfeiting and Piracy. Spain is positioned as a pioneer country against counterfeiting drugs.